- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04888689
Holter of Movement in Patients With Multiple Sclerosis in Controlled Environment.
Holter of Movement in Patients With Multiple Sclerosis. Acti-SEP Study: Controlled Environment.
ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. We plan to include a group of approximately 20 patients with MS.
This study include a unique evaluation in the laboratory of analysis of human movement. A set of tasks will be performed by patients wearing of two magneto-inertial sensors.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Liège, Belgium, 4000
- Centre Hospitalier Regional De La Citadelle
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Liège, Belgium, 4000
- Laboratoire d'Analyse du Mouvement Humain
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Confirmed MS diagnosis,
- Over 18 years old,
- Ambulant patients,
- Signed informed consent,
- No clinical and / or radiological relapse within 3 months.
Exclusion Criteria:
- Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
- Any other previous or present pathology having an impact on motor function.
- Recent surgery or trauma (less than 6 months) in the upper or lower limbs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MS patients
Ambulant patients with multiple sclerosis
|
Actimyo° is an innovative device intended to be used in a home-based environment.
It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
IMU is a portable system of miniaturized inertial sensors for objective, instrumental, ambulatory, and validated analysis of normal and pathological human gait. Each miniaturized inertial sensor (2 cm × 0.7 cm × 0.5 cm) includes a triaxial accelerometer and a triaxial gyroscope. These four inertial sensors are connected to a box by wires and are numbered 1 to 4. They must be attached - using adhesive tapes - on the participant's shoes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
95th centile of stride velocity
Time Frame: One day
|
95th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
|
One day
|
50th centile of stride velocity
Time Frame: One day
|
50th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
|
One day
|
95th centile of stride length
Time Frame: One day
|
95th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
|
One day
|
50th centile of stride length
Time Frame: One day
|
50th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
|
One day
|
Stance phase time
Time Frame: One day
|
Stance time over full stride time for each foot obtained with magneto-inertial sensors and a motion capture device (percentage).
|
One day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Margaux Poleur, MD, CHR Citadelle-CHU liège
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ActiSEP. Part 1.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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University of MinnesotaMallinckrodtTerminatedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
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Dr. Stéphanie DelstancheQueen Fabiola Children's University Hospital; Erasme University Hospital; SYSNAV and other collaboratorsActive, not recruiting
-
Institut de Myologie, FranceCompletedParkinson Disease | Healthy VolunteersFrance